Status:

COMPLETED

The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Schering-Plough

Conditions:

HIV Infections

Hepatitis C

Eligibility:

All Genders

13+ years

Phase:

PHASE1

Brief Summary

To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy of treatmen...

Detailed Description

IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with c...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Treatment or suppression of opportunistic infections with standard drugs.
  • Pneumovax, HIB, tetanus, influenza, and hepatitis B vaccines.
  • Clinically indicated antibiotics.
  • Short courses of steroids (< 21 days) for acute problems not related to hepatitis C.
  • Other regularly prescribed medications such as analgesics, nonsteroidal anti-inflammatory agents, antipyretics, allergy medications, and oral contraceptives.

Patients must have:

  • HIV positivity.
  • Documented hepatitis C virus.
  • CD4 count <= 200 cells/mm3.
  • No severe liver disease (Grade C Childs-Pugh classification) or chronic liver disease not caused by hepatitis C.
  • Willingness to be followed for the duration of treatment and follow-up period.

Prior Medication:

Allowed:

  • Prior AZT, ddI, and ddC.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Hepatitis B (HBsAg positive).
  • Autoimmune hepatitis (FANA titer >= 1:160 and anti-smooth muscle antibody titer >= 1:160).
  • Wilson's disease.
  • alpha-1 antitrypsin deficiency.
  • Hemochromatosis.
  • Malignancy requiring systemic chemotherapy.

Concurrent Medication:

Excluded:

  • Nonnucleoside analog therapy for HIV.
  • Biologic response modifiers.
  • Systemic cytotoxic chemotherapy.
  • Chronic systemic steroid use.

Concurrent Treatment:

Excluded:

  • Radiation therapy other than local irradiation to the skin.

Prior Medication:

Excluded:

  • Prednisone within 12 weeks prior to study entry (if patient has received prior daily doses for 1 month or longer duration).
  • Acute therapy for an infection within 2 weeks prior to study entry.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

September 1 1996

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT00001035

End Date

September 1 1996

Last Update

April 30 2012

Active Locations (3)

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Page 1 of 1 (3 locations)

1

USC CRS

Los Angeles, California, United States

2

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, United States, 462025250

3

NY Univ. HIV/AIDS CRS

New York, New York, United States, 10016

The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections | DecenTrialz